Regulatory Strategy & Submissions

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Regulatory Strategy & Submissions


Whether this is the first or tenth product you have brought to market, careful preparation for each milestone and possible challenge is necessary or your entire development strategy could be derailed. Planning is key to this process, and knowledge of each regulatory agency’s intricacies is a major plus.

Whether you need help executing your entire regulatory strategy, producing an FDA briefing package, or conducting a Pre-IND Meeting, The Weinberg Group’s experience and positive working relationship with the FDA means we will get the job done right. We work with you to do what is necessary to move to the next milestone.

Our Project-Based Regulatory Strategy and Submission Services Include:

  • Regulatory Strategy
  • FDA Meetings
    • Pre-IND Meeting
      • To the best extent possible, any meeting with the FDA should end in clarity.  During the Pre-IND Meeting Sponsors have the chance to discuss the requirements for opening an IND with the Agency.
    • End of Phase 2 Meeting
      • During this meeting, you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
    • Pre-NDA Meeting
      • When you leave your Pre-NDA Meeting, you should have an understanding of the FDA’s expectation for content.
      • During the Pre-NDA Meeting, you must make the most of the opportunity to solicit comments and clarification from the FDA on the acceptability of:
        • Pivotal clinical data, including late-breaking data that might become available for submission during the FDA’s review of the NDA
        • CMC information and, in particular, the extent of stability data
        • Content of the ISE and ISS sections
    • FDA Advisory Committee Meetings
      • Each Advisory Committee is different and has specific needs and concerns, and you must keep these in mind as you discuss your product.
  • FDA Submissions
    • IND Submission
      • The sooner you can begin your clinical trials, the sooner your product will be on the market, and in order to prevent any hiccups in this process, your final IND submission must be error free and contain all of the required information.
    • NDA Submission: 505(b)(1) and 505(b)(2) Assistance
      • As you can imagine, this type of submission requires extensive research, including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought.
    • Orphan Designation
    • ANDA Submission
      • Nearly 90% of ANDAs are not accepted by the FDA for review on the first pass. We have the knowledge and expertise you need to increase your chances of beating the odds, saving you both time and resources.
  • Regulatory Due Diligence

 

To learn more about how The Weinberg Group can help with all of your regulatory consulting needs, contact us today.